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NCT00634647 · ClinicalTrials.gov registry record · Phase 2
Satraplatin and Prednisone to Treat Prostate Cancer
A Phase 2 study of Prostate Cancer and Genetic Polymorphism, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT00634647: Completed Phase 2 study of Prostate Cancer and Genetic Polymorphism, sponsored by National Cancer Institute (NCI).
NCT00634647 is a Phase 2 study of Prostate Cancer and Genetic Polymorphism that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634647, a Phase 2 study of Prostate Cancer and Genetic Polymorphism, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer. Prednisone is approved for treating prostate cancer. The gene excision repair cross-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by satraplatin. It is possible that patients who have a variant of this gene will not benefit from treatment with satraplatin because the drug will not be able to damage the cancer cells effectively. Objectives: To determine if satraplatin may help treat prostate cancer in patients with certain variants of the ERCC1 gene. Eligibility: Patients with advanced androgen-independent prostate cancer whose disease has not responded to hormonal therapy or at least one type of chemotherapy and whose x-rays, scans or other tests have shown their cancer to be spreading. Design: Participants have a blood test to determine if they have a variant of the ERCC1 gene. Participants take satraplatin by mouth every day for 5 consecutive days out of every 35 days and prednisone by mouth every day. These 35-day treatment cycles may continue for 6 months or longer, depending on the benefits and side effects of the treatment. During the treatment period, patients undergo the following tests and procedures: * Blood tests on days 1 of the treatment cycle. * Weekly blood draws for the first 3 treatment cycles. * Imaging studies (e.g., bone scans, computed tomography (CT) scans) every two cycles to determine the response to treatment. * Surgical or medical suppression of testosterone in patients whose cancer cells continue to grow due to exposure to the hormone....
Primary Outcome
Time between the start of therapy and progression. Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive Disease is at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Conditions Studied
Interventions
- DRUG prednisone
- DRUG Satraplatin
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
- Associates in Oncology and Hematology - Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2008-02-19 |
| Est. Completion | 2012-05-01 |
| Phase | Phase 2 |
What the finished NCT00634647 record still lists
NCT00634647 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which prednisone is the first listed.
NCT00634647 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00634647 about?
NCT00634647 is a clinical study titled "Satraplatin and Prednisone to Treat Prostate Cancer". Background: Satraplatin is an experimental drug that may be of benefit to patients with prostate cancer. Prednisone is approved for treating prostate cancer. The gene excision repair cross-complementing rodent repair deficiency complementation group 1 (ERCC1) helps repair cell damage caused by sa...
What is the current status of trial NCT00634647?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2008-02-19. Estimated completion is 2012-05-01.
What conditions does trial NCT00634647 study?
This clinical trial studies the following conditions: Prostate Cancer, Genetic Polymorphism.
What interventions are being tested in trial NCT00634647?
The interventions under investigation include: prednisone (DRUG), Satraplatin (DRUG).
Who is sponsoring clinical trial NCT00634647?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00634647 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00634647's enrollment target sits among peer trials
24 634th of 735 higher than 97 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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